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Assessment and Grading of Oral Mucositis After Stem Cell Transplantation

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Assessment and Grading of Oral Mucositis After Stem Cell Transplantation Assessment and Grading of Oral Mucositis after Stem Cell Transplantation Corey Cutler, MD MPH FRCP(C) Dana-Farber Cancer Institute Brigham and Women’s Hospital Harvard Medical School Boston, Massachusetts Stomatitis A fish hook lodges in my throat. Spittle, kindergarten paste, thickens everything – even vision. Mouth, pocked with sores & blisters, swollen ulcerated tongue. Topside, sandpapered with number 7 coarsest grade. Taste buds, saliva glands, seared. Cool water, corrosive acid now. The tongue rests; teeth become enemies. Coiled steel razored wire atop dentate prison walls. Only moans escape my lips. I cannot eat or speak. Inside a howl festers. Pain lengthens time. – Anita Hart Balter NEJM. 1990;322:704. Oral Mucositis ♦Side Effect of Standard Cytotoxic Chemotherapy – Effect on tissues with rapid cell turnover – Bone Marrow - Myelosuppression – Hair Follicles - Alopecia Mouth – GI system - Diarrhea Esophagus - Esophagitis - Oral mucositis Stoma ch Small Intestine Colon Rectum Anal Can al and Anus 1 Close to 400,000 Patients Per Year Suffer From Mucositis During Cancer Therapy Breast Colorectal 14% 21% Stem Cell Transplant 4% NHL Head and 5% Neck 15% NSCLC 41% Source: Mattson Jack Database 2003; NCI; Note: 400,000 patients in the US Oral Mucositis: The Worst Complication of Myeloablative Transplantation 45 Most Debilitating Side Effects 40 35 ) % 30 ( s t n 25 e d n 20 o p s e 15 R 10 5 0 Oral Nausea and Weakness Diarrhea Mucositis Vomiting and Lethargy Adapted from Bellm LA et al, Support Care Cancer. 2000;8:33-39. For Every 55 Patients with Severe Mucositis and Myelosuppression… 41 will develop infection … and 5 will die. Elting, et al; Cancer 2003 2 Relationship of Mucositis to Outcomes in BMT Increase in Days: Health Outcome Mucositis vs. No Mucositis Injectable narcotics 4.80 (<0.01) TPN days 5.34 (<0.01) Febrile days 1.59 (<0.02) Significant infection 2.55 (<0.05) Hospital days (autos) 11.02 (<0.01) Hospital days (allos) 6.92 (<0.02) Pathobiology of Mucositis Phases II & III Messaging, Phase IV Normal Phase I Signaling, Ulceration Phase V Epithelium Initiation & Amplification (Mucositis) Healing Radiation Bacteria Chemotherapy Submucosa Basal Cell Blood Vessel Inflammatory Fibroblast Cell Epithelial Layer Clinical Features of Mucositis ♦Erythema ♦Ulceration ♦Pseudomembrane formation ♦Consequences – Pain – Difficulty in swallowing/chewing food – Decreased nutrition – Requirement for IV nutrition – Infectious risk – Breakdown of mucosal barrier – Risk of bacteremia secondary to TPN 3 4 Reasons to ‘Measure’ Mucositis ♦Toxicity description and assessment ♦Medical management ♦Research – Descriptive studies – Intervention studies Ideal Mucositis Scale ♦Accurately reflects severity and course of objective and subjective clinical changes. ♦Easy to teach and use, with minimal inter- observer variability. ♦Does not require lesion measurement. ♦Sensitive enough to discriminate treatment efficacy. ♦Clinically meaningful and easily interpretable end points for clinicians, patients, and FDA. Mucositis Research Instruments ♦No uniformity in end points. ♦Wide range of complexity. ♦Provide tight, comparable data, but meaningfulness of end points may be difficult to convey in general clinical settings, ie. How important is a difference between 1.62 vs. 0.77? ♦Major value in phase 2 trials and outcome analyses, but of limited value in phase 3 trials. 5 Mucositis Scale Frequency WHO NCI CTC Undefined Collaborative study RTOG Bearman Other Mucositis Scales to be Reviewed WHO Oral Toxicity Scale (WHO Score) NCI-CTC v3 Mucositis Scale Clinical Score Functional/Symptomatic Score OMAS WHO Score ♦ Based on a combination of subjective, objective and functional outcomes: ♦ Subjective– Soreness as described by the patient ♦ Objective – Presence of erythema and ulcerations ♦ Functional– Ability to eat solids, liquids or nothing by mouth 6 WHO Score ♦ Grade 0 – No objective findings, function irrelevant ♦ Grade 1 – Erythema plus pain, function irrelevant – May include mucosal scalloping with or without erythema or soreness ♦ Grade 2 – Ulceration, ability to eat solids ♦ Grade 3 – Ulceration, ability to eat liquids ♦ Grade 4 – Ulceration, nothing by mouth WHO Oral Mucositis Scale Severe oral mucositis Grade 0 1 2 3 4 None Soreness +/– Erythema, Ulcers, extensive Mucositis erythema ulcers erythema to the extent that alimentation is not No ulceration Patients can Patients cannot possible swallow solid swallow solid diet diet Diet Assessment – Food Definitions ♦Solids – Foods that have to be chewed – Chunky soups, meats, grains, pasta or whole vegetables ♦Liquids – Foods that take the shape of their container – Pureed soups, Jell-O®, pudding, mashed potatoes, baby food, Ensure® or other liquid supplement ♦Nothing Per Os – No eating or drinking, except enough liquid to allow for taking of medications 7 WHO Scale Grading Nuances Pain in the absence of objective findings = 0 Erythema without pain = 0 Ulcers, automatically ≥ 2 Extent or size of ulcers is not a driver WHO Grading Tips Grade 1 : If there is an ulcer, it’s not Grade 1 : May include mucosal scalloping with or without erythema or soreness. Grade 2 : Can’t be a Grade 2 unless there is an ulcer. Solid diet. Grade 3 : Ulcers. Liquid diet. No solids. Grade 4 : Mucositis of such severity that eating/drinking is impossible. : PO meds don’t count WHO Grading Examples Subject has a fetanyl patch, large ulceration, 4 no erythema, can eat Jello® and pudding Subject is taking an NSAID (within the last 24 hrs) for mouth pain, is now not sore and has 0 erythema Subject has no erythema, no soreness, can 2 eat solids and has an ulcer Subject has severe erythema, mouth pain and can only tolerate liquids 1 8 NCI-CTC v3 Scoring ♦ Two Components 1. Clinical Score – Objective findings 2. Functional/Symptomatic Score – Functional findings CTC Clinical Score ♦ 0 = No oral mucositis ♦ 1 = Erythema ♦ 2 = Patchy ulceration or pseudomembrane formation ♦ 3 = Confluent ulceration or pseudomembrane, confluent ulceration occupies >50% of the mucosal surface of the designated anatomic site ♦ 4 = Tissue necrosis CTC Functional/Symptomatic Score ♦1 = Ability to eat solids ♦2 = Requires liquid diet ♦3 = Not able to tolerate a solid or liquid diet ♦4 = Symptoms associated with life-threatening consequences ♦NOTE: If diet is limited for reasons other than mucositis, the CTC Functional/Symptomatic Score is based on what the subject feels he/she could eat. 9 Anatomic Site-Directed Scoring ♦Inner aspect of upper lip ♦Inner aspect of lower lip ♦Right cheek mucosa ♦Left cheek mucosa ♦Right bottom and side of tongue ♦Left bottom and side of tongue ♦Floor of mouth and frenulum ♦Soft palate Oral Mucositis Assessment Scale (OMAS) Sonis et al, Cancer 1999 Correlations Between Peak OMAS Score and Selected Clinical and Economic Outcomes Febrile days 0.13 Sig infection 0.26* TPN days 0.39* Injectable-narcotic days 0.36* Total hospital days 0.28* Total hospital charges 0.48* 10 How Frequently Should Evaluations Be Done? ♦ Depends on the reason for the assessment. ♦ Mucosal condition in chemotherapy responds relatively acutely. ♦ Consequently, accuracy of assessment tracks well with frequency of evaluation. ♦ Since duration of significant mucositis is the most important driver of untoward outcomes of mucositis, less than daily assessment is risky, especially in clinical trials. Why Does Mucositis Matter ♦ BMT CTN 0401 – Will intervention make mucositis worse??? ♦ BMT CTN 0402 – Will intervention make mucositis better??? ♦ New interventions exist - Palifermin 0401: Bexxar-BEAM vs BEAM ♦ Autologous transplantation – standard for relapsed non-Hodgkin’s Lymphoma – Usual regimen: High-dose chemotherapy – BEAM or equivalent. – 0401 – Tests hypothesis that the addition of 131I-Tositumomab to high-dose chemotherapy will increase response rate Æ survival – BUT: Addition of radio-immunotherapy may increase mucositis 11 Pathobiology of Mucositis Phases II & III Messaging, Phase IV Normal Phase I Signaling, Ulceration Phase V Epithelium Initiation & Amplification (Mucositis) Healing Radiation Bacteria Chemotherapy Submucosa Basal Cell Blood Vessel Inflammatory Fibroblast Cell Epithelial Layer 0402: Effect of Methotrexate Elimination Retrospective cohort analysis (2001-2003) Cohorts designated by GVHD prophylaxis: Sirolimus/Tacrolimus vs. Tacrolimus/Methotrexate Cy-TBI MRD PBSCT Oral Mucositis Mucositis assessed 2-3x/week by members of the Oral Medicine service OMAS scale Other Outcomes Total Parenteral Nutrition Total number of days of use recorded Narcotic use Conversion of all narcotics to intravenous mg morphine equivalents (MME) using accepted conversion factors Duration of Hospitalization From day of transplantation to 1st discharge 12 Data Siro / Tacro Tacro / Mtx p Sample Size 30 24 Median Age 42 (19-54) 43 (24-58) 0.46 Male Gender 16 (53%) 11 (46%) 0.78 Malignancy AML/MDS 15 (50%) 16 (67%) CML 7 (23%) 3 (13%) NHL/ALL 8 (27%) 5 (21%) 0.52 Time To ANC > 500 14 (11-17) 15 (11-25) 0.04 Gr II-IV GVHD 3 (10%) 6 (25%) 0.16 Mucositis Assessments 5 6.5 0.36 Mucositis Incidence Duration of Mucositis 60 ST group TM group 30 50 p = 0.0002 p = 0.008 40 15 20 25 20 30 10 Mucositis (days) 10 Mucositis Incidence (%) Duration of Ulcerative 05 0 0-1 2-3 4-5 ST group TM group Peak Mucositis Score TPN usage Days of TPN required ST group 80 TM group p = 0.08 p = 0.005 30 60 40 Duration of TPN Usage Duration of Patients Requiring TPN(%) Patients Requiring 01020 020 ST group TM group 13 Narcotic Utilization p = 0.08 p = NS p = NS p
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